Intravenous essential fatty acid emulsion

a technology of essential fatty acids and emulsions, which is applied in the direction of depsipeptides, organic active ingredients, peptide/protein ingredients, etc., can solve the problems of high percentage of av graft failure rate, low or inadequate blood flow of av grafts, mixed antiplatelet or anticoagulation regimens used in an attempt to reduce the av graft failure rate,

Inactive Publication Date: 2007-07-05
DRAGTEK CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Unfortunately, a high percentage of AV grafts develop low or inadequate blood flow due to stenosis or thrombosis within weeks or months of implantation.
Antiplatelet or anticoagulation regimens used in an attempt to reduce the AV graft failure rate have met with mixed results.
The unwanted side effects of antiplatelet or anticoagulation regimens have all but precluded such approaches to reduce the high incidence of vascular access failures.
Unfortunately, AV fistulas, likewise have drawbacks.
One such drawback is that it takes time for the vein to grow larger to create a robust and enlarged ‘rapidly flowing lake’ of blood for purposes of hemodialysis.
The most common complications are infection and low blood flow due to blood clotting.
Compared with AV fistulas, AV grafts tend to have more complications associated with clotting or infection requiring replacement of the AV graft.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0055] A fish oil emulsion is prepared for intravenous administration during hemodialysis. The fish oil emulsion contains 10 g of fish oil, 2.5 g glycerol and 1.2 g egg-yolk lecithin per 100 ml, i.e., Omegaven® (Fresenius Kabi, Bad Homburg, Germany), making up a 10% solution. The fish oil is highly refined and contains at least 40% long chain omega-3 fatty acids. The omega-3: omega-6 ratio is 1:4.

[0056] The commercially available sterile glass vial of Omegaven® is checked for any precipitation and discarded if present. The container is thoroughly shaken and the emulsion container therein is accessed via an infusion set using standard sterile procedures. The emulsion is infused into the drip chamber for the venous blood line at the distal end of the dialyzer.

[0057] The infusion of the Omegaven® emulsion begins after approximately 15 minutes of dialysis. The emulsion is infused continuously at a rate not to exceed 0.5 ml / kg / hour until 4 g of the emulsion have been infused.

example 2

[0058] A 20% omega-3 concentration emulsion is infused over 2.5 to 3 hours, according to Example 1, to meet the dosage requirements of approximately 4 g per dialysis session.

example 3

[0059] A fish oil and vegetable oil emulsion combination is prepared for intravenous administration during hemodialysis. The combination emulsion contains 10 g of fish oil, 2.5 g glycerol and 1.2 g egg-yolk lecithin per 100 ml, i.e., Omegaven® (Fresenius Kabi, Bad Homburg, Germany), in combination with a flax seed oil emulsion containing 5 g of flax seed oil i.e., ALA 75 (BioGin Biochemicals Co., Ltd, Chengdu, China) making up a 15% solution. The fish oil is highly refined and contains at least 40% long chain omega-3 fatty acids with an omega-3: omega-6 ratio of 1:4 and the flax seed oil contains at least 70% long chain omega-3 fatty acids with an omega-3:omega-6 ratio of 4:1 ratio.

[0060] The emulsion is infused into the drip chamber for the venous blood line at the distal end of the dialyzer. Alternatively, the infusion can also be administered through a central or peripheral venous line.

[0061] The infusion of the emulsion begins after approximately 15 minutes of dialysis. The em...

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Abstract

A method for preventing stenosis and thrombosis of an AV graft is disclosed. An essential fatty acid emulsion is administered to the patient through the AV graft, preferably during dialysis, whereby the anti-inflammatory properties of the essential fatty acid emulsion prevent complications typical of AV grafts.

Description

SCOPE OF THE INVENTION [0001] The present invention relates to compositions including essential fatty acids suitable for intravenous administration to a patient in need thereof to reduce or eliminate inflammatory responses, as well as methods of making and using the same. More specifically, the present invention relates to compositions including an essential fatty acid emulsion suitable for intravenous use prior to or during hemodialysis to prevent or reduce stenosis and / or thrombosis of a vascular access. BACKGROUND OF INVENTION [0002] Hemodialysis is the most common method used to treat advanced and permanent kidney failure. Since the 1960's, when hemodialysis first became a practical treatment for kidney failure, many advances have been made to make hemodialysis treatments more effective and to minimize side effects. During hemodialysis, a patient's blood is allowed to flow through tubing, a few ounces at a time, into a hemodialysis machine. The hemodialysis machine has three pri...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/18A61K38/43A61K31/714A61K31/59A61K31/525A61K31/51A61K31/401A61K31/22A61K31/366A61K38/29
CPCA61K9/0019A61K9/107A61K33/30A61K33/06A61K38/29A61K38/1816A61K35/60A61K31/22A61K31/366A61K31/401A61K31/51A61K31/525A61K31/59A61K31/714A61K2300/00A61P25/00A61P29/00A61P3/02A61P35/00A61P37/02A61P7/02A61P9/00A61P9/06A61P9/08A61P9/12A61K38/43A61K38/18
Inventor BORTZ, JONATHAN DAVIDLEVINSON, R. SAUL
Owner DRAGTEK CORP
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